NDC Code(s) : 69904-0001-1
Packager : Accupack Midwest

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Arnica Pain ReliefMenthol CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69904-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL3.7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
POLYSORBATE 20(UNII: 7T1F30V5YH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
MELALEUCA ALTERNIFOLIA LEAF(UNII: G43C57162K)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL(UNII: Y050HYR4XA)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
WATER(UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
TROLAMINE(UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69904-0001-185 g in 1 JAR Type 0: Not a Combination Product19/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/19/2015

PRINCIPAL DISPLAY PANEL

Pain Cream Template